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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Predates Commission Regulation (EU) 2016/1688
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
predates establishment of OECD 406 guideline
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study was commissioned prior to the passage of Commission Regulation (EU) 2016/1688 amending Regulation (EC) No. 1907/2006 on these testing obligations.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tributyl O-acetylcitrate
EC Number:
201-067-0
EC Name:
Tributyl O-acetylcitrate
Cas Number:
77-90-7
Molecular formula:
C20H34O8
IUPAC Name:
tributyl 2-acetoxypropane-1,2,3-tricarboxylate
Test material form:
liquid: viscous
Details on test material:
Unilever product, ca 1976. no data on purity

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: 0.01% Dobs/saline
Concentration / amount:
Induction: 2.5% in 0.01% Dobs/saline.
Induction-dermal: (occlusive patch application) with 100%.
Challenge (covered patch application) with 50% in absolute ethanol
Day(s)/duration:
21
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Induction: 2.5% in 0.01% Dobs/saline.
Induction-dermal: (occlusive patch application) with 100%.
Challenge (covered patch application) with 50% in absolute ethanol
Day(s)/duration:
21
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
50%
Day(s)/duration:
7
Adequacy of challenge:
highest non-irritant concentration
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
50%
Day(s)/duration:
7
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 (one dose group)
Details on study design:
Ten guinea pigs according to the Magnusson-Kligman guinea pig maximization test method. Sensitization was induced by intradermal injections of both test substance and Freunds Adjuvant and the induction process supplemented seven days later by the test substance applied to the shoulder injection sites (2 in x 2 in) under occlusion (adhesive plaster, Poroplast, wound around trunk). The animals were challenged by occluded patch 14 days later. Second and third challenges were made in a weekly interval.
Challenge controls:
negative controls: 4 vehicle treated and 4 non-treated
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
One animal killed in extremis
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50% induction
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
no indication of skin sensitisation
Remarks:
same results at 48 h
Key result
Reading:
other: Rechallenge #2
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
no indication of skin sensitisation
Remarks:
all resolved at 48 h

Any other information on results incl. tables

Animal 2 was killed in extremis due to an ulcerated neck application site. The positive reactions were mild and no more extreme than reactions in vehicle and/or untreated controls. Essentially none was considered a true positive.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
GHS
Conclusions:
The test substance, ATHC, showed no evidence of sensitisation in guinea pigs, under the conditions of a guideline Magnusson Kligman Maximisation Test. Two rechallenges were undertaken on the test animals in order to verify the absence of sensitisation.